19. What Will Happen after IRB Review?

As a result of its review, the MMC IRB may decide to approve or disapprove the proposed research activity, or to specify modifications required to SEQuR IRB approval of the research activity. Except when the expedited review procedure is used, these actions will be taken by a vote of a majority of the regular and alternate members present, except for those members present but unable to vote in accordance with the IRB's conflict of interest policies. When reviewed via expedited review, the Chairperson or designee can take any of the following actions except to disapprove a study.

Specific Policies and Determinations:

The IRB may make one of the following determinations as a result of its review of research submitted for initial review or for continuing review:

Approved: The protocol and accompanying documents are approved as submitted. Final approval will commence on the day the study is approved by an action of the convened IRB or Chairperson or designee and expire within one (1) year of the meeting date, but not later than the day preceding the date of review. Approvals are always considered conditional. The conditions for continued approval, and the time frame (if any) within which they must be met will be clearly stated in the approval letter. If the conditions of the approval are not met, approval may be withdrawn.

Withheld (conditional) Approval: Minor modification of, or addition to, a protocol or accompanying document(s) is required. Changes will be voted upon during the IRB's meeting, as well as the terms of approval. The Investigator will be informed in writing of the required changes and requested information and must provide the IRB with the changes or information.

Tabled: Significant questions are raised by the proposal requiring its reconsideration after additional information is received from the Sponsor and/or Investigator.

Disapproval: The proposal fails to meet one or more criteria used by the IRB for approval of research. Disapproval cannot be given through the expedited review mechanism and may only be given by majority vote at a convened meeting of the IRB.